Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence]

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2014

Specific Treatments:

acquired hemophilia A

Therapeutic Areas

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General Information

Obizur is a recombinant porcine FVIII treatment. Obizur temporarily replaces the inhibited endogenous factor VIII that is needed for effective hemostasis in patients with acquired hemophilia A.

Obizur is specifically indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

Obizur is supplied as a powder for solution for intravenous use after reconstitution only. The recommended initial dose of Obizur is 200 units per kg. The dose and frequency of administration should be titrated based on factor VIII recovery levels and individual clinical response. 

Clinical Results

FDA Approval

The FDA approval of Obizur was based on a global, prospective, controlled, multi-center phase II/III open-label clinical trial that examined the efficacy of Obizur in the treatment of serious bleeding episodes in adults with acquired hemophilia A (29 patients evaluated for safety, 28 evaluated for efficacy). All subjects treated with Obizur showed a positive response, meaning an effective or partially effective response with bleeding stopped or reduced and clinical improvement, at 24 hours after the initial infusion. A total of 86% had successful treatment of the initial bleeding episode. The overall treatment success was determined by the investigator based on the ability to discontinue or reduce the dose and/or dosing frequency of Obizur.

Side Effects

Adverse effects associated with the use of Obizur may include, but are not limited to. the following:

  • development of inhibitors to porcine factor VIII.

Mechanism of Action

Obizur is a recombinant porcine FVIII treatment. Obizur temporarily replaces the inhibited endogenous factor VIII that is needed for effective hemostasis in patients with acquired hemophilia A.

Additional Information

For additional information regarding Obizur or acquired hemophilia A, please visit www.baxter.com